Coherus BioSciences Reports Third Quarter 2017 Operating and Financial Results
November 06 2017 - 3:00PM
Coherus BioSciences, Inc. (Nasdaq:CHRS), today reported financial
results and reviewed corporate events for the third quarter ended
September 30, 2017.
Corporate Highlights for the Third Quarter 2017
Include:Immunology (anti-TNF) therapeutic
franchise:
- CHS-0214 (etanercept (Enbrel®) biosimilar candidate)
- Filed petitions for Inter Partes Review (“IPR”) in
the United States Patent and Trademark Office seeking invalidation
of U.S. Patents 8,163,522 (“ ‘522 patent”) and
8,063,182, - (“ ’182 patent”). Both are generally
directed to the etanercept protein, the pharmaceutically active
component of Enbrel - We expect the PTAB to enter
decisions on whether to institute these two IPRs by March 13, 2018
(for the ’522 patent) and by March 26, 2018 (for the ‘182
patent).
- CHS-1420 (adalimumab (Humira®) biosimilar candidate)
- Reported topline results from a pharmacokinetic
bioequivalence (“PK BE”) study comparing CHS-1420 to European
marketed Humira. The study met the criteria for clinical PK BE on
all prospectively defined endpoints and there were no clinically
meaningful differences in the safety profile between the two
products.
Financial Highlights for the Third Quarter and
year-to-date 2017
- Cash used in operations was $41.5 million in
the third quarter, down 25% from the $55.6 million used in the
second quarter of 2017 and down 43% from the $73.3 million used in
the first quarter of 2017. In August 2017, we announced that
Temasek, an investment company headquartered in Singapore, plans to
invest up to $150 million over two tranches. We received the first
tranche of $75 million in aggregate proceeds on August 24, 2017 and
issued 6,556,116 shares of common stock at an offer price of
$11.4397 per share. The second tranche is projected to be
funded following receipt of the U.S. Food and Drug Administration’s
marketing approval for the CHS-1701 pegfilgrastim biosimilar
product candidate, subject to market pricing and certain closing
conditions at that time, including each party’s final
approval.
- Research and development (R&D) expenses
for the third quarter of 2017 were $42.6 million, as compared to
$64.6 million for the same period in 2016. R&D expenses
for the nine months ended September 30, 2017 were $130.9 million,
as compared to $195.4 million for the same period in 2016.
Decreases in R&D expenses were mainly attributable to the
decline and end of clinical activities for CHS-0214, CHS-1420 and
CHS-131 during the preceding twelve months.
- General and administrative (G&A) expenses
for the third quarter of 2017 were $14.0 million, as compared to
$13.6 million for the same period in 2016. G&A expenses
for the nine months ended September 30, 2017 were $56.3 million, as
compared to $36.3 million for the same period in 2016.
Changes in G&A expenses were mainly attributable to legal and
other professional fees to support intellectual property litigation
and IPRs, as well as personnel related costs to support CHS-1701
pre-commercial activities in the first six months of 2017.
- Net loss attributable to Coherus for the third
quarter of 2017 was ($59.0) million, or ($1.09) per share, as
compared to net income attributable to Coherus of $83.9 million, or
$1.67 per share, for the same period in 2016.
- Cash, cash equivalents and investments
in marketable securities – short term totaled $150.1
million as of September 30, 2017, as compared to $118.3 million as
of June 30, 2017.
Guidance for the fourth quarter of 2017 and first half
of 2018:
CHS-1701 (pegfilgrastim (Neulasta®)
biosimilar)
- Anticipate resubmitting the BLA in the U.S. mid-first quarter
of 2018 subject to meeting with FDA.
- Anticipate European opinion in the first half of 2018, such
timing being dependent upon data requests.
- Commercial partnering discussions continue to be underway for
certain ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis®)
biosimilar)
- Prioritizing the development of CHS-3351.
CHS-1420 (adalimumab
biosimilar)
- Continue to optimize manufacturing.
CHS-0214 (etanercept
biosimilar)
- Focus on regulatory issues through the first half of 2018.
- Provide revised guidance on filing of the marketing
authorization application in Europe after CHS-1701 U.S. BLA
resubmission.
- Continue to optimize manufacturing.
- Targeting immunology (anti-TNF) partnering therapeutic
franchise agreement.
CHS-131 central nervous system anti-inflammatory
asset
- Completing additional animal studies on CHS-131 to further
validate its mechanism of action and address drug-derived
metabolites. Licensing agreement to follow subject to
results.
Cash flow
- Anticipate cash use in operations of approximately $35 - $40
million in the fourth quarter of 2017, down approximately $5
million from previous guidance, and $30 - $35 million per quarter
in the first half of 2018.
Conference Call Information
When: November 6, 2017 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587
(International)
Conference ID: 99333721
Webcast: http://investors.coherus.com
Please join the conference call at least 10 minutes early to
register. The webcast will be archived on the Coherus
website.
About Coherus BioSciences,
Inc.Coherus is a leading pure-play, global biosimilar
company that develops and commercializes high-quality therapeutics
for major regulated markets. Biosimilars are intended for use in
place of existing, branded biologics to treat a range of chronic
and often life-threatening diseases, with the potential to reduce
costs and expand patient access. Composed of a team of proven
industry veterans with world-class expertise in process science,
analytical characterization, protein production, sales &
marketing and clinical-regulatory development, Coherus is
positioned as a leader in the global biosimilar marketplace.
Coherus is advancing three late-stage clinical products towards
commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-1420
(adalimumab biosimilar), CHS-0214 (etanercept biosimilar), and
CHS-3351 (ranibizumab biosimilar) as well as developing a robust
pipeline of future products in four therapeutic areas, oncology,
immunology (anti-TNF), ophthalmology and multiple sclerosis. For
additional information, please visit www.coherus.com.
Forward-Looking StatementsExcept for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Coherus’ plans,
potential opportunities, expectations, projections, goals,
objectives, milestones, strategies, product pipeline, preclinical
and clinical studies, product development, release of data and the
potential benefits of its products under development are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
including Coherus’ ability to resubmit a BLA in the US and receive
marketing approval in Europe for CHS-1710; make advances in the
development of CHS-3351; continue to advance its intellectual
property strategy and complete partnering agreements for CHS-1420
and CHS-0214; file an MAA for CHS-0214; and complete additional
studies and a licensing agreement for CHS-131. Such forward-looking
statements involve substantial risks and uncertainties that could
cause our clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in the clinical drug development process, including the regulatory
approval process, the timing of our regulatory filings and other
matters that could affect the availability or commercial potential
of our biosimilar drug candidates, as well as possible patent
litigation. Coherus undertakes no obligation to update or revise
any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Coherus’ business in general, see
Coherus’ Quarterly Report on Form 10-Q for the quarter ended
September 30, 2017, filed with the Securities and Exchange
Commission on November 6, 2017 and its future periodic reports to
be filed with the Securities and Exchange Commission.
Enbrel® and Neulasta® are registered trademarks of Amgen
Inc.Humira® is a registered trademark of AbbVie Inc.Lucentis® is a
registered trademark of Genentech, Inc.
|
|
Coherus BioSciences, Inc. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
September 30, |
|
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
(unaudited) |
|
(unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
- |
|
|
$ |
162,835 |
|
|
$ |
1,556 |
|
|
$ |
189,262 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
42,626 |
|
|
|
64,573 |
|
|
|
130,901 |
|
|
|
195,430 |
|
|
General and administrative |
|
13,989 |
|
|
|
13,645 |
|
|
|
56,325 |
|
|
|
36,303 |
|
|
Total operating expenses |
|
56,615 |
|
|
|
78,218 |
|
|
|
187,226 |
|
|
|
231,733 |
|
|
Income
(loss) from operations |
|
(56,615 |
) |
|
|
84,617 |
|
|
|
(185,670 |
) |
|
|
(42,471 |
) |
|
Interest
expense |
|
(2,392 |
) |
|
|
(2,420 |
) |
|
|
(7,152 |
) |
|
|
(5,611 |
) |
|
Other
income (expense), net |
|
14 |
|
|
|
1,647 |
|
|
|
3,605 |
|
|
|
(3,762 |
) |
|
Net
income (loss) |
|
(58,993 |
) |
|
|
83,844 |
|
|
|
(189,217 |
) |
|
|
(51,844 |
) |
|
Net loss attributable
to non-controlling interest |
|
4 |
|
|
|
95 |
|
|
|
114 |
|
|
|
428 |
|
|
Net income (loss)
attributable to Coherus |
$ |
(58,989 |
) |
|
$ |
83,939 |
|
|
$ |
(189,103 |
) |
|
$ |
(51,416 |
) |
|
Net income (loss) per
share attributable to Coherus |
|
|
|
|
|
|
|
|
Basic |
$ |
(1.09 |
) |
|
$ |
1.93 |
|
|
$ |
(3.68 |
) |
|
$ |
(1.25 |
) |
|
Diluted |
$ |
(1.09 |
) |
|
$ |
1.67 |
|
|
$ |
(3.68 |
) |
|
$ |
(1.25 |
) |
|
Weighted-average number of shares used in computing net
income (loss) per share attributable to Coherus |
|
|
|
|
|
|
|
|
Basic |
|
54,070,872 |
|
|
|
43,469,986 |
|
|
|
51,377,836 |
|
|
|
41,096,783 |
|
|
Diluted |
|
54,070,872 |
|
|
|
51,581,298 |
|
|
|
51,377,836 |
|
|
|
41,096,783 |
|
|
|
|
|
|
|
Coherus BioSciences, Inc. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
Cash and
cash equivalents |
$ |
135,557 |
|
$ |
124,947 |
|
Investments in marketable securities - short-term |
|
14,493 |
|
|
- |
|
Other
assets |
|
39,708 |
|
|
53,538 |
|
Total
assets |
$ |
189,758 |
|
$ |
178,485 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Deferred
revenue |
$ |
- |
|
$ |
1,561 |
|
Convertible notes |
|
75,944 |
|
|
75,192 |
|
Convertible notes-related parties |
|
25,314 |
|
|
25,064 |
|
Other
liabilities |
|
33,593 |
|
|
57,314 |
|
Total
stockholders' equity |
|
54,907 |
|
|
19,354 |
|
Total
liabilities and stockholders’ equity |
$ |
189,758 |
|
$ |
178,485 |
|
|
|
|
|
|
CONTACT:Patrick O’BrienSenior Vice President, Investor
RelationsCoherus BioSciences, Inc.pobrien@coherus.com+1 (650)
649-3527
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